2001
The Consortium is formed on the initiative of the Cystic Fibrosis Trust.
2002-2003
Reorganisation of the three groups and creation of specific working groups and core facilities at each of the three sites.
2004
Development of the first CpG-Free plasmids.
Start of the product evaluation study to assess the effectiveness of multiple gene transfer agents (GTAs) in pre-clinical studies.
2005
End of product evaluation. GL67A selected as gene transfer agents (GTAs) for clinical studies.
2006
Tracking Study commences.
Creation of a modular clinical plasmid design (after extensive plasmid development).
hCEFI promoter established as having superior duration of expression in pre-clinical models (after multiple promoter elements are tested).
The clinical trial plasmid pGM169 produced in Oxford.
Large scale production of pGM169 from E.coli 'paste' at VGXi, Houston, Texas.2007
Completion of the Tracking Study.
Commercial manufacturing of GL67A and pGM169 begins.
Testing and selection of clinical nebulisers.
Extensive clinical assay development ahead of clinical studies.
Design of a mixing device for correct mixing of GL67A and pGM169.
2008
Run-in Study commences.
2009
Single Dose Clinical Trial (Pilot study) commences.
2010
Extensive pre-clinical multi-dose toxicology studies commence (these are required by law ahead of multi-dose studies in CF patients).
2011
Completion of Single Dose Clinical Trial (Pilot study).
Extensive pre-clinical multi-dose toxicology studies completed.
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2012 - Proposed
Start of multi-dose Clinical trial to assess efficacy of GL67/pGM169 formulation.
2013 - Proposed
End of multi-dose Clinical trial towards the end of 2013.
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